The concept of informed consent was developed in order to protect research study participants from the potential harm that can result from taking part in a research study. Informed consent involves two key parts: a document and a process.
The informed consent form is an official document that summarizes the details of the research study and explains the rights of the participants. This document must be signed by the research subjects (or their parents) and the researchers. Research subjects are often given a copy of the informed consent form once it has been signed by all parties so that they can contact the researchers in the future when they have a question about the research study protocol.
The informed consent form serves as the beginning of the informed consent process, which is a conversation between potential research subjects and the researchers. The goal of the informed consent process is to educate potential participants about whether to begin or continue participation in a research study. Researchers know that the written informed consent form, no matter how well-written, may not ensure that potential research subjects fully understand what participating in a research study means. In order to help potential subjects make an informed decision, researchers discuss the research study’s purpose, procedures, benefits, risks, and rights with potential subjects.